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The MicroSTAAR® Injector System (MSI) is a device intended to fold and insert STAAR® Surgical Company Collamer® phakic and aphakic 1-piece intraocular lenses for surgical placement into the human eye.

The MicroSTAAR® Injector System Cartridge (MSI Cartridge) is designed to facilitate the loading, folding and delivery of Collamer® phakic and aphakic intraocular lenses (ICL/IOL) into the human eve through a small incision. There is one model of MSI Cartridge in this submission, SFC-45 cartridge. The SFC-45 Cartridge is designed to lock into a corresponding MicroSTAAR® Injector System. The cartridge has a loading area on one end and a tapered tip on the other. The SFC-45 has a funnel shape, with exposed flat loading areas, and was designed to work with the Collamer® 1piece lenses manufactured by STAAR Surgical.

The provided document is a 510(k) summary for the MicroSTAAR® Injector System Cartridges, specifically concerning a change in the polypropylene material used for manufacturing. The document describes several performance tests conducted to demonstrate that the device, with the new material, is substantially equivalent to its predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• The document does not explicitly state the sample sizes for each individual test (biocompatibility, feasibility, shelf-life, sterilization).
• Data Provenance: The biocompatibility study was performed by "Namsa Laboratory." No country of origin is explicitly mentioned for the data, but the company (STAAR Surgical) is based in the USA, and the material supplier is in Japan. The study is retrospective in the sense that these tests were performed on a device with a modified material to demonstrate equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• This information is not applicable to the type of device and studies described. The tests performed are engineering and laboratory-based assessments (e.g., cytotoxicity, material analysis, mechanical function, sterility), not clinical evaluations requiring expert interpretation of diagnostic images or patient outcomes. Therefore, "ground truth" in the sense of expert consensus on clinical data is not relevant here.

4. Adjudication Method for the Test Set:

• Not applicable. As the tests are objective laboratory and functional evaluations, there is no need for an adjudication method as would be used in expert consensus for clinical image interpretation.

5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is an intraocular lens injector cartridge, a mechanical device used in surgery, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI effect size are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• For biocompatibility, the ground truth is established by standard biological assays and the absence of cytotoxic, sensitizing, or irritating effects as per ISO 10993 standards.
• For feasibility, the ground truth is successful delivery of the lenses without damage, as determined by visual inspection and functional assessment.
• For FTIR, the ground truth is the chemical fingerprint of polypropylene copolymer.
• For shelf-life, the ground truth is the continued functional performance and integrity of the cartridge after accelerated aging, meeting manufacturer's specifications.
• For sterilization, the ground truth is the achievement of the specified Sterility Assurance Level (SAL), demonstrated by biological indicators.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not a machine learning model that requires a training set. The "training" in this context refers to the development and manufacturing processes that establish the device's characteristics.

9. How the ground truth for the training set was established:

• Not applicable. See point 8. The "ground truth" for the device design and manufacturing is established through engineering specifications, material science principles, and adherence to quality system regulations (e.g., 21 CFR 820). The studies described here are verification and validation activities against those established specifications.

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The DK7786 handpiece is used in combination with the One Series™ Ultra Cartridge to fold and assist in inserting TECNIS® 1-Piece intraocular lenses. ONLY into the capsular bag.

Duckworth & Kent Ltd Model DK7786 Injector

The provided text is a 510(k) clearance letter from the FDA for a medical device: "Duckworth & Kent Ltd. Injector DK 7786". This document does not contain information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

The letter explicitly states that the device is a Class I product (KYB) and has been found substantially equivalent to a legally marketed predicate device. This type of clearance typically relies on a comparison to existing devices rather than a new clinical study with specific performance metrics.

Therefore, I cannot provide the requested information based on the input text. The prompt asks for details that are not present in this regulatory document.

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The Medicel IOL Injector Set and Cartridge for intraocular lenses is indicated for the insertion only of models of intraocular lenses that allow use of this injector in their approved labeling.

The Medicel IOL Injector Set for intraocular lenses is intended to insert foldable intraocular whose labeling specifies this injector. The injector is available as reusable or single-use. The cartridge is single-use and is provided sterile. The device has two basic components: an injector (available either reusable or single use) and a disposable cartridge, sold sterile. The single-use injector is made of plastic and is sold sterile. The re-usable injector is made of titanium and can be autoclaved. The cartridge is made of lubricated polypropylene.

The provided document is a 510(k) summary and FDA clearance letter for a medical device: the Medicel A.G. IOL Injector Set. This submission is for a traditional medical device, not an AI/ML-enabled device. Therefore, the questions regarding acceptance criteria, study details, and performance metrics related to AI/ML are not directly applicable to this document.

However, I can extract the information relevant to the device's performance testing as described in the document.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. It indicates that the device was tested for biocompatibility and compatibility with recommended intraocular lenses.

Regarding the other questions, they are not applicable or cannot be answered from the provided document as it concerns a traditional medical device, not an AI/ML product.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable for this traditional medical device. The document mentions "The device was tested with each of the recommended intraocular lenses" but does not specify a sample size for these tests or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not an AI/ML device relying on expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The performance is based on physical testing and comparison to predicate devices, not medical ground truth.

8. The sample size for the training set
Not applicable. There is no training set for a non-AI/ML device.

9. How the ground truth for the training set was established
Not applicable.

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The MONARCH® III IOL Delivery System is used for implantation of ALCON® qualified ACRYSOF® intraocular lenses into the eye following cataract removal.

The Monarch© III IOL Delivery System is a modification to the previously cleared Alcon Monarch(r) II IOL Delivery System (K003768) consisting of a disposable cartridge and reusable handpiece. The Monarch II cartridges are designated as A, B, and C, and feature various nozzle tip sizes that correspond to the various AcrySof® IOL models. As with the cleared cartridges, the Monarch© III IOL Delivery System presented in this submission utilizes a one-piece disposable cartridge (designated as D) with progressive folding in combination with a reusable handpiece (H4). This new cartridge possesses the same basic inner lumen design and lens guiding mechanisms as the existing Monarch*) II A, B, and C cartridges, but differs in nozzle tip sizing.

The document provided is a 510(k) summary for the Alcon Monarch® III IOL Delivery System. It is a premarket notification to the FDA to demonstrate substantial equivalence to previously marketed devices. The summary outlines the device description, indications for use, and a brief summary of nonclinical tests. However, it does not contain detailed acceptance criteria, specific study results proving device performance against those criteria, or the other specific information requested in your prompt (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, training set details).

This document is a regulatory submission, not a detailed scientific study report. It states that Alcon will conform to requirements but doesn't provide the test results or the specific acceptance criteria themselves.

Therefore, I cannot provide the requested table and detailed study information based on this document.

Here's an explanation of why the requested information is absent:

• Acceptance Criteria & Reported Performance: The document states that the device "will conform in all respects with the requirements set forth in the FDA Intraocular Lens Guidance Document (Draft released 10/14/1999) Section C. Mechanical Testing, 5. Folding and Injection Testing prior to marketing the product." This is a statement of intent to conform to guidance, not a set of specific, quantified acceptance criteria or a report of the device's performance against them.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth): This type of detailed information would typically be found in a comprehensive test report or clinical study report, which is usually part of the full 510(k) submission but not typically included in the public 510(k) summary. For a device like an IOL delivery system, the "ground truth" often relates to mechanical integrity, successful delivery without damage to the IOL or ocular structures, and consistent performance, rather than expert consensus on images.
• Training Set Information: This device is a mechanical delivery system, not an AI or image-based diagnostic tool. Therefore, concepts like "training set," "ground truth for the training set," "experts," and "MRMC studies" are generally not applicable in the context of this type of medical device submission.

In summary, the provided text confirms:

• Device Name: Monarch® III IOL Delivery System (D Cartridge and H4 Handpiece)
• Indication for Use: Implantation of ALCON® qualified ACRYSOF® intraocular lenses into the eye following cataract removal.
• Regulatory Clearance: K063155, cleared March 27, 2007.
• Nonclinical Test Summary: "Alcon has provided a Statement of Conformance... that the Monarch® III IOL Delivery System... will conform in all respects with the requirements set forth in the FDA Intraocular Lens Guidance Document (Draft released 10/14/1999) Section C. Mechanical Testing, 5. Folding and Injection Testing prior to marketing the product."

No further details regarding specific acceptance criteria, study methodologies, statistical results, or expert involvement are present in this 510(k) summary.

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The Akreos Single Use Insertion Device should only be used to fold and deliver those IOL models that allow use of this injector in their approved labeling.

Akreos Single Use Insertion Device, Model AI-28, previously known as Hydroport SI, is validated for folding and delivering the Bausch & Lomb one-piece Akreos Advanced Optics Aspheric Intraocular Lens (IOL) into the eye during cataract surgery. Future IOL models may also by qualified with the Akreos Single Use Insertion Device following fold and recovery validation studies. The device provides a small tubular pathway in which the Akreos Advanced Optics Aspheric Lens can be placed into the eye with one continuous forward motion. The Akreos Single Use Insertion Device consists of two parts: a syringe shaped tube (includes lens loading deck and lens cap) with a plunger, and a transition cell. The Akreos Single Use Insertion Device is a sterile (EtO), disposable plastic device, designed for single use only.

Here's an analysis of the provided text regarding the Akreos Single Use Insertion Device, Model AI-28, addressing your specific questions.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the test set for any of the performance or safety tests. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the involvement of any experts to establish ground truth for the device's performance testing. The reported performance refers to non-clinical performance data and testing rather than expert evaluations of clinical outcomes.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method, as the reported studies are primarily non-clinical performance and safety tests, not studies requiring expert interpretation or consensus on a dataset.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a physical medical instrument (an IOL insertion device), not an AI-powered diagnostic or interpretive tool that would involve human readers. Therefore, the concept of human readers improving with AI assistance is not applicable here.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable to the Akreos Single Use Insertion Device. This device is a physical tool for delivering an IOL. It does not involve algorithms or AI. Its performance is inherent to its mechanical properties and design when used by a surgeon.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

• Non-clinical performance data: Specifically, the ability to successfully fold and deliver the specified IOL into an in vitro or simulated setting ("fold and recovery testing").
• Material properties data: Results from stability testing (tensile and flexural properties).
• Biocompatibility testing results: Demonstrating the safety of the materials.
• Sterilization and Shelf-life test results: Confirming the device maintains its properties and sterility.

There is no mention of pathology, expert consensus on clinical cases, or outcomes data from human use as "ground truth" for this specific submission's documented performance.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical instrument, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set was Established

This question is not applicable, as there is no training set for this device.

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The Collamer 3 Piece IOL Injector, is an intraocular lens guide used to ford and into the capsular bag or ciliary sulcus following cataract extraction.

The Collamer 3 Piece Injector is made of titanium alloy designed for inserting intraocular lenses into the human eye following cataract extraction. The Collamer 3 Piece Injector materials and mechanical behavior are similar to those used with the predicate device.

The provided document is a 510(k) summary for the STAAR Surgical Collamer 3 Piece Injector, and it describes a medical device (injector), not an AI/ML powered device, therefore most of the requested information (like acceptance criteria for an AI model, sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) is not applicable to this document.

However, I can extract the information relevant to the device's performance based on the provided text, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Here's the relevant information:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance: Not applicable. This is not a study assessing an AI/ML algorithm's performance on a dataset. The testing described is non-clinical mechanical performance testing of a physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML algorithm is not relevant here.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an AI algorithm.

7. The type of ground truth used: Not applicable. The "ground truth" in this context would be the objective measurements and observations of the physical device's mechanical performance and behavior, compared to a predicate device and safety standards.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary of the Study:

The study described is a non-clinical test to demonstrate the substantial equivalence of the Collamer 3 Piece Injector to its predicate device, the MS1-P Elastic Lens Injector (K861085). The study focused on validating the mechanical performance and mechanical behavior of the new injector.

The device meets the (implicit) acceptance criteria because the non-clinical tests showed that it performs equivalently to the predicate device in terms of mechanical performance and behavior, and it was designed and tested in accordance with applicable safety standards. The FDA's clearance letter (K032412) confirms that the device is substantially equivalent, allowing it to be marketed.

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The Mastel 1 Folder™ Implantation System is intended to fold and assist in inserting the SENSAR™, model AR40e intraocular lens, ONLY into the capsular bag.

The Mastel 1 Folder is an ophthalmic surgical device designed for use in inserting a foldable intraocular lens into the eye. The materials, basic scientific concepts, physical properties and intended use of the Mastel 1 Folder are similar to those of the predicate devices.

The Mastel 1 Folder Implantation System is comprised of a medical-grade titanium handpiece, a material commonly used in reusable surgical devices. The handpiece rod is designed to accept a single-use cartridge. The handpiece is reusable and is designed to withstand conventional in-office steam autoclaving. The handpiece is provided to the customer in a plastic case in a non-sterile state.

Acceptance Criteria and Study for Mastel 1 Folder™ Implantation System

1. Table of Acceptance Criteria and Reported Device Performance

This document summarizes the safety and effectiveness for a device that is a mechanical inserter; therefore, the "acceptance criteria" are related to maintaining the physical integrity and optical properties of the intraocular lenses (IOLs) during the insertion process. The reported device performance indicates successful delivery of IOLs without degradation of their critical parameters.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: 130 intraocular lenses (IOLs), ranging from 6.0 D to 23.0 D.
• Data Provenance: The study was an in vitro performance test. The country of origin of the data is not specified, but the submission is to the U.S. FDA, suggesting the testing was conducted to U.S. standards, likely in the U.S. or by a U.S. entity. The data is prospective in the sense that it was specifically generated for the submission to demonstrate device performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The study was an in vitro performance test of a mechanical device's ability to handle and deliver intraocular lenses without damaging them or altering their critical physical and optical characteristics. The "ground truth" was established by objective measurements of the IOLs post-delivery against their known specifications/tolerances. No human expert interpretation of images or clinical outcomes was involved in establishing this in vitro performance ground truth.

4. Adjudication method for the test set

Not applicable. As described above, the "ground truth" was derived from direct physical and optical measurements of the IOLs. There was no need for expert adjudication because the assessment was objective and quantitative, comparing measured parameters against acceptable ranges.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a mechanical intraocular lens implantation system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone in vitro performance test was conducted. The device (Mastel 1 Folder Insertion System) was used to deliver 130 intraocular lenses, and the IOLs were subsequently evaluated for various physical and optical parameters. This test assesses the device's performance directly and independently of any human-in-the-loop clinical use evaluation.

7. The type of ground truth used

The ground truth used was based on objective physical and optical measurements of the intraocular lenses (IOLs) after being processed by the device. These measurements (diopter, astigmatism, resolution, visual acuity characteristics, overall diameter, loop angles, and sagitta) were compared against acceptable standards or specifications for IOLs, ensuring the device did not negatively impact their functional integrity.

8. The sample size for the training set

Not applicable. This device is a mechanical tool, not an artificial intelligence or machine learning system. Therefore, there is no "training set" in the context of algorithm development.

9. How the ground truth for the training set was established

Not applicable. As this is a mechanical device and not an AI/ML system, no training set or its associated ground truth establishment methods are relevant.

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The Disposable MicroSTAAR™ Injector (Model MSI-P1) is a device used to fold and insert STAAR Surgical UV-ELASTICT™ silicone lenses for surgical placement in the human eye.
The Disposable MicroSTAAR™ Injector is a device used to fold and insert STAAR Surgical Company UV-ELASTIC™ single-piece silicone lenses for surgical placement in the human eye.

The Disposable MicroSTAART™ Injector (Model MSI-P1) is used to fold and insert STAAR Surgical UV-ELASTICTM silicone intraocular lenses for surgical placement in the human eye. Like other MicroSTAAR injectors it provides a sterile tubular pathway through a surgical incision, over the iris and into either the ciliary sulcus or the capsular bag of the eye. The Disposable MicroSTAART™ Injector (Model MSI-P1) is made from plastic and the inner dimensions of the delivery pathway, as well as the outer dimensions of the portion that contacts the eye tissues are identical to STAAR Surgical Company's currently marketed injection systems. The Disposable MicroSTAART™Injector (Model MSI-P1) is provided sterile and is designed for single use.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Premarket Notification [510(K)] Summary for the Disposable MicroSTAAR™ Injector System

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Functional Testing:
  • Sample Size: Thirty (30) sterile Disposable MicroSTAAR™ Injectors (Model MSI-P1).
  • Data Provenance: Not explicitly stated but implies laboratory testing done by the manufacturer (STAAR Surgical Company) as part of their validation. It is a prospective test, as it's a validation performed for the device.
• Accelerated Aging Study:
  • Sample Size: "Baseline (zero time) and one year accelerated samples" were used. The exact number of samples for each specific test (Microbial Challenge, Dye Penetration, Peel Strength, Burst) is not explicitly stated, but it would have been a subset of the manufactured devices.
  • Data Provenance: Similar to functional testing, this was likely a prospective laboratory study conducted by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is generally not applicable to mechanical device testing like an IOL injector. The "ground truth" here is objective physical measurements and performance thresholds (e.g., absence of tears, resolution measurements, integrity assessments). No human experts were used to establish a ground truth in the sense of image interpretation or diagnosis.

4. Adjudication Method for the Test Set

Not applicable. The tests involve objective measurements against predefined criteria, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance

Not applicable. This device is a mechanical injector, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a mechanical injector, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these tests was based on objective, measurable physical characteristics and performance criteria for the device and its packaging. This includes:

• Absence of physical damage: Lens tears.
• Performance metrics: Optical resolution post-ejection.
• Sterility integrity: Microbial challenge results, dye penetration, peel strength, burst strength.
• Statistical similarity: For aging studies, comparing mechanical properties of new vs. aged samples.

8. The Sample Size for the Training Set

Not applicable. This is a mechanical device, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a mechanical device.

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